FDA.report

ZeroWire

Primary DI
00818089022017
Brand
ZeroWire
Company
Nds Surgical Imaging LLC
Model
90T2073
Device description
CUSTOM KARL STORZ US, ZEROWIRE G2 DUO, DVI, SDI
Published
2022-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818089022017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818089022017008180890220178180890220170818089022017

GMDN Terms

TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081712583
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00818089022437Radiance90R01302026-02-10
00818089021270Endovue90X06992024-03-28
00818089023021ENDOVUE90X07262024-03-13
00818089020112ScaleOR 90T00092022-10-15
00818089023007Radiance 90Z03032022-10-15
00818089023014Radiance 90Z03042022-10-15
00818089022994Radiance 90X07242022-09-30
00818089021164Radiance 90X06862022-08-11
00818089021171Radiance 90X06872022-08-11
00818089021188Radiance 90X06952022-08-11
00818089021232EndoVue90X07122022-08-11
00818089021263EndoVue90X06982022-08-11
00818089021287EndoVue90X07002022-08-11
00818089021584Radiance 90X06972022-08-11
00818089022475Radiance 90X07132022-08-11
00818089022482Radiance 90X07152022-08-11
00818089022499Radiance 90X07142022-08-11
00818089022505EndoVue90X07082022-08-11
00818089022512Radiance 90X07162022-08-11
00818089022659ZeroWire G2 90Z1782022-08-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417888MillenniumAvalign Technologies, Inc.GCJ2026-03-11
B382SD4387110Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD481753PTSTR0Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817570Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817590Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
00198506088964ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089060ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089077ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089084ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
B382SD56534910Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD56740240Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD76500310Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
04251303824985BLUEENDOTROKAMED GmbHGCJ2026-02-27
00198506088704ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088711ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088216ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088483ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088490ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23